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Q: Shelf life of drug eluting stents ( Answered 5 out of 5 stars,   3 Comments )
Question  
Subject: Shelf life of drug eluting stents
Category: Health > Conditions and Diseases
Asked by: crystal4290-ga
List Price: $20.00
Posted: 17 Apr 2005 17:55 PDT
Expires: 17 May 2005 17:55 PDT
Question ID: 510603
What is the average shelf life for drug eluting stents for human use? 
I heard that they had very short shelf lives.

Clarification of Question by crystal4290-ga on 17 Apr 2005 17:57 PDT
By shelf life, I mean, how long is the product good on the shelf when
is comes from the manufacturer - not how long does it last in a human.

Request for Question Clarification by bobbie7-ga on 18 Apr 2005 13:53 PDT
Hi Crystal4290,

I posted some information in the comment box below for you to review. 

Thanks,
Bobbie7

Clarification of Question by crystal4290-ga on 18 Apr 2005 14:36 PDT
Hello again Bobbi7 - 

Excellent job - this is PERFECT!!!!!
Answer  
Subject: Re: Shelf life of drug eluting stents
Answered By: bobbie7-ga on 18 Apr 2005 14:43 PDT
Rated:5 out of 5 stars
 
Dear Crystal4290,

I'm delighted that my findings are helpful!

I will repost them below for your convenience.

Best wishes,
Bobbie7

-----------------------------------------

It appears that the average shelf life of drug-eluting stents is six months.

If  this information serves your purpose, please let me know and I
will post my findings as your official answer.

Thanks,
Bobbie7

Excerpts:

FDA Approves Extension of Expiration Date for TAXUS? Express2?
Paclitaxel-Eluting Stent System to Nine Months

Decision adds three months to current U.S. shelf life of product 

? Boston Scientific Corporation (NYSE: BSX - News) today announced
that the U.S. Food and Drug Administration (FDA) has approved
extending the shelf life of its TAXUS Express2 paclitaxel-eluting
coronary stent system in the United States to nine months from the
current shelf life of six months. The decision was based on data
submitted by Boston Scientific to the FDA that demonstrated the
performance of the TAXUS system -- in particular the drug content,
drug degradation profile, and drug-release mechanism -- was maintained
within FDA- approved specifications at nine months.

The extended expiration date applies to all sizes of the TAXUS system
for sale in the United States. The Company said it would immediately
begin updating labels to reflect the nine-month expiration date. The
shelf life for the TAXUS system outside the United States remains
unchanged at 18 months.

August 2004
http://www.ptca.org/press_rel/20040819pr_boston.html

Drug-eluting Stent news
http://www.ptca.org/news_des.html


Six months

?Cordis spokesperson Terri Mueller told HPN insisted that the company
is "on target with its rollout plan in the U.S." But others say two
factors have contributed to issues with availability. The first blip
entails the product's relatively short shelf life (six months) because
of its piggybacked pharmaceutical.?
http://www.findarticles.com/p/articles/mi_m0BPC/is_8_27/ai_107199462
crystal4290-ga rated this answer:5 out of 5 stars and gave an additional tip of: $5.00
This is exactly what I wanted to know - and I even got the answer rapidly!  Perfect!

Comments  
Subject: Re: Shelf life of drug eluting stents
From: bobbie7-ga on 18 Apr 2005 13:52 PDT
 
Hello again Crystal4290, 

It appears that the average shelf life of drug-eluting stents is six months.

If  this information serves your purpose, please let me know and I
will post my findings as your official answer.

Thanks,
Bobbie7

Excerpts:

FDA Approves Extension of Expiration Date for TAXUS? Express2?
Paclitaxel-Eluting Stent System to Nine Months

Decision adds three months to current U.S. shelf life of product 

? Boston Scientific Corporation (NYSE: BSX - News) today announced
that the U.S. Food and Drug Administration (FDA) has approved
extending the shelf life of its TAXUS Express2 paclitaxel-eluting
coronary stent system in the United States to nine months from the
current shelf life of six months. The decision was based on data
submitted by Boston Scientific to the FDA that demonstrated the
performance of the TAXUS system -- in particular the drug content,
drug degradation profile, and drug-release mechanism -- was maintained
within FDA- approved specifications at nine months.

The extended expiration date applies to all sizes of the TAXUS system
for sale in the United States. The Company said it would immediately
begin updating labels to reflect the nine-month expiration date. The
shelf life for the TAXUS system outside the United States remains
unchanged at 18 months.

August 2004
http://www.ptca.org/press_rel/20040819pr_boston.html

Drug-eluting Stent news
http://www.ptca.org/news_des.html


Six months

?Cordis spokesperson Terri Mueller told HPN insisted that the company
is "on target with its rollout plan in the U.S." But others say two
factors have contributed to issues with availability. The first blip
entails the product's relatively short shelf life (six months) because
of its piggybacked pharmaceutical.?
http://www.findarticles.com/p/articles/mi_m0BPC/is_8_27/ai_107199462
Subject: Re: Shelf life of drug eluting stents
From: bobbie7-ga on 18 Apr 2005 16:33 PDT
 
Thank you very much for the five stars, kind words and nice tip!
--Bobbie7
Subject: Re: Shelf life of drug eluting stents
From: angiodude-ga on 26 May 2005 21:40 PDT
 
The latest info (which has changed recently) is that the Taxus stent
now has an approved shelf life of 12 months in the U.S. and 18 months
outside. The Cypher stent has a 3 month shelf life approved for the
U.S. and 5 months outside. News about this can be found at
http://www.ptca.org/news_des.html#TAXUS_SHELF

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